OrthoNext™ Platform System Software 1.1
OrthoNext™ Platform System Software 1.1 (JPSMODULESW) is a Class II device made by Orthofix SRL, cleared under FDA 510(k) K242270 on 19 Dec 2024 (1 earlier submission) and listed in FDA GUDID since 31 Mar 2023 (UDI-DI 18053340345682), active as of 12 Nov 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK242270 | Date19 Dec 2024 | StatusActive |
| United States | GUDID listing | Number18053340345682 | Date31 Mar 2023 | StatusListed |
Official records
- AccessGUDID record 18053340345682
- FDA 510(k) database K242270
- FDA 510(k) database K202519
Across registries
- FDA 510(k) K242270 decided 19 Dec 2024 Active
- FDA GUDID UDI-DI 18053340345682 listed 31 Mar 2023 Listed
Timeline
- Cleared FDA 510(k) K202519
- Listed FDA GUDID 18053340345682
- Cleared FDA 510(k) K242270
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- OrthoNext™ Platform System Software
- Generic name
- Radiological PACS-dedicated management software
- Model / Ref / Catalog
- 1.1, JPSMODULESW
- Primary DI / UDI-DI
- 18053340345682
- FDA product code
- QIH
- GMDN term
- Radiological PACS-dedicated management software
- Device class
- Class II
- Regulation number
- 892.2050
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under Radiological PACS software.
- McKesson Radiology 12.3 by Change Healthcare Canada Company
- INFINITT Cardiology PACS by INFINITT Healthcare Co., Ltd.
- Change Healthcare Radiology Solutions 14.0 by Change Healthcare Canada Company
- INFINITT RT PACS by INFINITT Healthcare Co., Ltd.
- Visage Ease Pro 2.2 by Visage Imaging, Inc.
- Vitrea Software Package VSTP-002A by CANON INC.
- Sidexis 4 6773258 by SIRONA Dental Systems GmbH
- ContourProtégéAI - CT Thorax 1.0 by MIM SOFTWARE INC.